Azurvig

Patient Information Leaflet

Azurvig, 12.5 mg per measured dose, oral suspension
Sildenafil
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Azurvig is and what it is used for
2. What you need to know before you take Azurvig
3. How to take Azurvig
4. Possible side effects
5. How to store Azurvig
6. Contents of the pack and other information

1. What Azurvig is and what it is used for

Azurvig contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. The medicine works by helping to relax blood vessels in the penis, increasing blood flow to the penis during sexual stimulation. Azurvig helps achieve an erection only if you are sexually stimulated.
Azurvig is used to treat erectile dysfunction in adult men, which is defined as the inability to achieve or maintain a penile erection sufficient for sexual intercourse.

2. Important Information Before Taking Azurvig

When not to take Azurvig

• If the patient is allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking nitrates, as their concomitant use may lead to a dangerous decrease in blood pressure. The patient should inform their doctor if they are taking any medicines from this group—these drugs are often used to relieve symptoms of angina (chest pain). In case of doubt, consult a doctor or pharmacist.
• If the patient is taking drugs that release nitric oxide (such as amyl nitrite, commonly known as "poppers"), as their simultaneous use may also lead to a dangerous drop in blood pressure.
• Severe heart or liver disease.
• Recent stroke or heart attack, or in cases of low blood pressure.
• Hereditary degenerative retinal disorders, such as retinitis pigmentosa.
• If the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION).
• If the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by blood clots). PDE5 inhibitors such as Azurvig have been shown to enhance the blood pressure-lowering effect of this drug. If the patient is taking riociguat or is unsure, they must inform their doctor.

Warnings and precautions
Before starting treatment with Azurvig, discuss with your doctor, pharmacist, or nurse if:

• The patient has sickle cell anemia (an abnormality of red blood cells), leukemia (a blood cancer), or multiple myeloma (a cancer of the bone marrow).
• The patient has been diagnosed with anatomical penile deformity or Peyronie's disease.
• Heart-related conditions. In such cases, the doctor should assess whether the heart condition allows for the additional strain associated with sexual activity.
• Peptic ulcer disease or bleeding disorders (such as hemophilia).
• Sudden decrease or loss of vision occurs—treatment with Azurvig must be stopped immediately and the patient should contact their doctor without delay.

Azurvig must not be used simultaneously with other oral or locally administered treatments for erectile dysfunction.
Azurvig must not be used concurrently with arterial pulmonary hypertension (APH) therapies containing sildenafil or other PDE5 inhibitors.
Azurvig must not be taken if erectile dysfunction has not been diagnosed. Azurvig is not intended for use in women.

Special considerations for patients with renal or hepatic impairment
Patients with impaired kidney or liver function should inform their doctor. The doctor may decide to prescribe a lower dose of Azurvig.

Children and adolescents
Azurvig oral suspension must not be used in individuals under 18 years of age.

Azurvig and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
If the patient is already taking riociguat, this must be reported to the doctor or pharmacist.
Azurvig may interact with certain medicines, particularly those used to treat chest pain. In case of worsening health requiring immediate medical attention, inform the doctor, pharmacist, or nurse about having taken Azurvig and the time of administration. Do not take Azurvig with other medicines unless directed by a doctor.
Do not take Azurvig if the patient is using nitrates, as their concomitant use may lead to a dangerous drop in blood pressure. Always inform the doctor, pharmacist, or nurse if the patient is taking nitrates used to treat angina (chest pain).
Do not take Azurvig if the patient is using drugs that release nitric oxide (such as amyl nitrite), as their combined use may also cause a dangerous decrease in blood pressure.
For patients taking protease inhibitors used in the treatment of HIV infection, it is recommended to start therapy with a lower dose (2 measured doses corresponding to 25 mg of sildenafil) of Azurvig.
Some patients taking alpha-blockers for high blood pressure or benign prostatic hyperplasia may experience dizziness or lightheadedness, which may be signs of low blood pressure caused by a rapid drop in blood pressure upon standing or sitting up quickly. Such symptoms have occurred in some patients taking Azurvig together with alpha-blockers. These are most likely to occur within 4 hours after taking Azurvig. To reduce the risk of such symptoms, the patient should be on a stable dose of their alpha-blocker before starting Azurvig. The doctor may decide to initiate treatment with a lower starting dose (2 measured doses corresponding to 25 mg of sildenafil) of Azurvig.
Inform your doctor or pharmacist if the patient is taking medications containing sacubitril with valsartan, used in the treatment of heart failure.

Taking Azurvig with food, drink, and alcohol
Azurvig may be taken with or without food. However, taking Azurvig with a heavy meal may delay the onset of its effect.
The ability to achieve an erection may be temporarily impaired after alcohol consumption. To maximize the therapeutic benefit of Azurvig, significant alcohol intake should be avoided before taking the medicine.

Pregnancy, breastfeeding, and fertility
Azurvig is not intended for use in women.

Driving and using machines
Azurvig may cause dizziness and visual disturbances. Patients should understand how they react to Azurvig before driving or operating machinery.

Azurvig contains sodium benzoate
This medicinal product contains 0.5 mg of sodium benzoate in 0.5 mL, equivalent to 1 mg/mL.

3. How to take Azurvig

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The recommended initial dose is 4 measured doses of the suspension, corresponding to 50 mg
of sildenafil.
The possibility of adjusting the dose according to concomitant diseases, tolerance, and efficacy for each patient is an important feature of the sildenafil-containing dosage form.
Azurvig is a prescription medicine, and therefore the doctor may prescribe it at the most appropriate dose, taking into account the individual characteristics of the patient. Azurvig enables the doctor to select the lowest effective dose using the same medicine, and facilitates dose titration and (or) ongoing adjustment if the patient's condition requires it, in accordance with medical criteria. This helps minimize adverse events.
The doctor's goal is to establish the optimal dose—sufficient to achieve the desired pharmacological effect, yet low enough to minimize adverse reactions.
Each measured dose contains 12.5 mg of sildenafil.

The maximum daily dose of the suspension is 4 measured doses, corresponding to 50 mg
of sildenafil.
Azurvig oral suspension must not be taken more than once a day.
Azurvig must not be taken with other medicines containing sildenafil.
Azurvig should be taken approximately one hour before planned sexual activity.
Azurvig is intended exclusively for oral administration.
It must not be administered intranasally or topically on the skin (local application).
The physician will prescribe the appropriate number of required doses.
Information on correct administration is provided in the Instructions for Use.
Always use the pump supplied in the Azurvig packaging.
Instructions for use:

1. Shake the bottle vigorously for 20 seconds to disperse any sediment before use. See Figure 1.

2. Remove the child-resistant cap by pressing firmly downward and turning to the left. See Figure 2.

3. Place the dosing pump on the bottle, carefully inserting the plastic tube into the bottle. Then hold the dosing pump in place at the neck of the bottle and turn it to the right until securely attached. See Figure 3.

4. Turn the dosing pump to the open position. See Figure 4.

5. Before each use (including first use): Prime the pump by pressing it three times to prepare (prime) the dosing pump. Discard the medication released during this priming onto an absorbent material. The pump is now ready for use, and each measured dose contains on average 12.5 mg of sildenafil. Failure to prime may result in an underdose being delivered.

Discard the medication when below the red line.

6. Tilt the head slightly backward. Place the pump in the mouth. Press the dosing pump as many times as required according to the dose recommended by the physician, and administer the suspension onto the tongue, immediately swallowing the suspension with saliva. Avoid direct contact between the tip of the dosing pump and the inside of the oral cavity or tongue. See Figure 5.

7. Turn the dosing pump to the closed position (Figure 6) and remove the pump by drawing it up along the inner wall of the bottle, unscrewing it to the left (Figure 7).

8. Close the bottle immediately after each use with the child-resistant cap (Figure 8).

9. Wash the entire dosing pump with water, ensuring by pressing the pump several times onto an absorbent material that no medication residue or water remains in the pump. Leave the pump to dry thoroughly before reuse. See Figure 9 and Figure 10.

The medicine should be stored out of sight and reach of children.
PATIENT NOTE – According to these instructions for use, which require priming the dosing pump before each use and washing the dosing pump, the bottle will contain an average final volume of 20 ml of oral suspension for administration.
The medicine should be stored out of sight and reach of children.
If you feel that the effect of Azurvig is too strong or too weak, consult your doctor or pharmacist.
Azurvig oral suspension enables an erection only in the presence of sexual stimulation. The time to onset of effect of Azurvig varies between patients, usually ranging from half an hour to one hour. The effect may occur later if the medicine is taken after a heavy meal. Contact your doctor if, after taking Azurvig, an erection does not occur or if the duration of erection is insufficient for sexual intercourse.
Taking more than the recommended dose of Azurvig
The patient may experience adverse reactions more frequently and with increased intensity.
Do not take more doses than prescribed by your doctor.
Contact your doctor if you have taken more doses than recommended.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions reported with the use of Azurvig are usually mild or
moderately severe and transient.
If any of the following adverse reactions occur,
stop taking Azurvig and seek immediate medical help:

• Allergic reaction – occurs uncommonly (may occur in 1 out of 100 patients). Symptoms: sudden wheezing, difficulty breathing or dizziness, swelling of the eyelids, face, lips or throat.
• Chest pain – occurs uncommonly. If it occurs during or after sexual intercourse:
• adopt a semi-sitting position and try to relax,
• do not take nitrates to relieve chest pain.
• Prolonged and sometimes painful erections – occurs rarely (may occur in 1 out of 1000 patients). If an erection lasts more than 4 hours, contact a doctor immediately.
• Sudden decrease or loss of vision – occurs rarely
• Severe skin reactions – occurs rarely. Symptoms may include severe peeling and swelling of the skin, formation of blisters in the mouth, on genital organs and around the eyes, fever.
• Seizures or convulsions – occurs rarely

Other adverse reactions:
Very commonly (may affect more than 1 in 10 patients): headache.
Commonly (may affect 1 in 10 patients): nausea, sudden flushing of the face, hot flushes (symptoms include a sensation of warmth in the upper body), indigestion, vision with a coloured aura, blurred vision, visual disturbances, stuffy nose, dizziness.
Uncommonly (may affect 1 in 100 patients): vomiting, skin rash, eye irritation, eye hyperaemia, eye pain, seeing flashes of light, bright vision, light sensitivity, tearing of the eyes, palpitations, rapid heartbeat, hypertension, hypotension, muscle pain, somnolence, reduced sense of touch, dizziness, tinnitus, dryness of the mouth, blocked or stuffy sinuses, nasal mucosal inflammation (symptoms include runny nose, sneezing and blocked nose), upper abdominal pain, gastro-oesophageal reflux disease (symptoms include heartburn), blood in urine, pain in hands or feet, nosebleeds, sensation of warmth, and feeling of fatigue.
Rarely (may affect 1 in 1000 patients): fainting, stroke, heart attack, irregular heartbeat, transient reduction in blood flow to part of the brain, sensation of tightness in the throat, numbness of the lips, bleeding into the back of the eye, double vision, reduced visual acuity, abnormal sensations inside the eye, swelling of the eyes or eyelids, small particles or spots in the visual field, seeing halos around light sources, pupil dilation, abnormal discolouration of the white part of the eye, penile bleeding, presence of blood in semen, dry nose, swelling inside the nose, feeling of irritation, and sudden hearing loss or deafness.
Since the medicine was placed on the market, rare cases of unstable angina (heart disease) and sudden death have been reported. It is important to note that in most, but not all, men who experienced these adverse reactions, pre-existing cardiac disorders were present before taking Azurvig.
It is not possible to determine whether these adverse reactions were related to the use of sildenafil.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Azurvig

Keep this medicine out of sight and reach of children.
For unopened bottle:
Store below 30°C. Do not use this medicine after the expiry date stated on the carton and bottle.
The expiry date refers to the last day of the stated month.
After first opening:
Do not use more than 10 months after the first opening of the bottle. Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Azurvig contains

• The active substance is sildenafil. 1 ml of suspension contains sildenafil citrate equivalent to 25 mg of sildenafil (35.1 mg as citrate salt). Each pump dose (0.5 ml of suspension) contains 12.5 mg of sildenafil (as citrate).
• Other ingredients: sodium benzoate, anhydrous citric acid, sucralose (E-955), acesulfame potassium (E-950), hypromellose (15 cP), xanthan gum, mint flavor 501500 TP0504 containing: corn maltodextrin, flavoring additives (menthofuran 0.6%, pulegone 0.2%, estragole 0.09%) and modified corn starch E-1450 (7.9%), taste-masking flavor SC241160 containing: natural flavoring substances, sucralose E-955 (94.5%), potato maltodextrin and monoammonium glycyrrhizinate (0.4%), purified water.

What Azurvig looks like and contents of the pack
Azurvig medicinal product is a white or almost white suspension, free from foreign particles, with a characteristic minty odour.
The primary packaging consists of high-density polyethylene (HDPE) bottles with a capacity of 30 ml, equipped with child-resistant closure comprising a high-density polyethylene (HDPE) cap, and containing a dosing pump delivering 0.5 ml per pump actuation.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alpen Pharma GmbH
Steinenfeld, 3
77736 Zell am Harmersbach
Germany
Telephone: +49 7243 2004910
Fax: +49 7835 634685

Manufacturer
Zinereo Pharma, S.L.U.
A Relva, s/n
36400 O Porriño, Pontevedra
Spain
Telephone: +34 986 345 200
Fax: +34 986 345 201

Farmalider, S.A.
C/ Aragoneses, 2
Alcobendas, Madrid
28108 Spain

or

Edefarm, S.L.
Polígono Industrial Enchilagar del Rullo, 117.
46191 Villamarchante – Valencia
Spain
Telephone: +34 962 79 37 17

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Bulgaria Azurvig 12.5 mg/pump actuation, oral suspension
Czech Republic Azurvig
Greece Azurvig 12,5 mg/πάτημα δοσομετρικής αντλίας, πόσιμο εναιώρημα
Hungary Azurvig 12.5 mg/pumpálásonként belsőleges szuszpenzió
Italy Azurvig
Poland Azurvig
Portugal Erepry 12,5 mg/aplicação da bomba doseadora suspensão oral
Romania Azurvig 12.5 mg/acționare a pompei, suspensie orală
Slovakia Azurvig 12.5 mg/dávka pumpy, perorálna suspenzia
France AZULVIG 12.5 mg/pression, suspension buvable
Croatia Azurvig 12.5 mg/ po potisku, oralna suspenzija

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl